21 CFR 882.4460 — Holder, Head, Neurosurgical (Skull Clamp)
Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4460
Identification
A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 2 | 50 | 3rd Party |